BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø3.3MM NC, SLA® 12MM, TIZR, LOXIM

    MDR report key: 16114455 · Received January 6, 2023

    Report

    Report Number
    0001222315-2023-000346
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    November 21, 2022
    Report Date
    January 6, 2023
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031706737
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022-08-01 IN ADA 22. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635192 BLT Ø3.3MM NC, SLA® 12MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA Roxolid BL HWF11 07630031706737

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention